Replies to post #32060 on Biotech Values

[walldiver]

GTOP vs OSIP pivotal Phase III

Dew, wasn't the Tarceva monotherapy trial in 2nd and 3rd-line NSCLC the only pivotal trial that OSIP conducted for that indication? In reading the company press releases, it was strongly implied that the p value threshold for that trial was 0.05.

Same thing with the Tarceva + Gemzar Phase III in pancreatic.

[gofishmarko]

Re : GTOP - Thanks Dew.


>>> In a strictly arithmetic sense, the appropriate hurdle when there is only one pivotal trial would be 0.0025 (0.05^2), not 0.025. However, the FDA rarely holds a sponsor to such a stringent threshold and usually gives at least 0.01 of cumulative p-value for a trial no matter what. <<<

That extra decimal point makes a big difference --- I need to get myself some more of that " arithmetic sense ". :-)

Even though the penalty is only to a .01 p instead of .0025 , it still seems like the prudent thing to do is run two trials if at all possible , unless the results are highly predictable.